Medical device package

ABSTRACT

The present disclosure provides a package for a medical device containing a cavity for receiving the medical device, a first closure having a sealed portal therein and a second closure adjacent the first closure.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S.Provisional Application Ser. No. 60/904,927, filed on Mar. 5, 2007, theentire disclosure of which is incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates generally to a package for medicaldevices, and more particularly, to a package including a first cavityfor receiving a medical device, a first closure for sealing the medicaldevice within the first cavity, the first closure including a sealedportal defined therein and a second closure positioned adjacent thefirst closure, the second closure surrounding the portal.

2. Background of Related Art

Combination medical devices, i.e., medical devices coated with drugs orother bioactive agents, have become more prevalent commercially inrecent years. There are many of these combination medical devices knownto those skilled in the art. Many of these devices require specializedcoatings to facilitate both bioactive agent elution and, moreimportantly, maintain or enhance the core functionality of the medicaldevice. For example, a suture containing an antimicrobial coating mustbe able to facilitate the elution of the antimicrobial agent in thecoating and also maintain a certain tensile strength, handling ability,knot-tying ability, and degradation rate to ensure the coated sutureremains functional as a wound closure device.

Further, with the selection of a new coating, drug or any combination ofmedical devices comes the challenge of marrying the selected agents witha coating or medical device that can accommodate both technicalrequirements described above, as well as the manufacturing, sterilizing,and transporting processes involved in producing such products. Thisoften requires the design of new coating polymers, which are specializedto be compatible with a specific agent, as well as new coating,manufacturing, sterilizing and transporting processes. In addition,designing these new coatings and processes creates the added pressuresof possibly impacting the shelf-life of the device as well as theend-use of the combination medical device in a negative manner.

Also, medical professionals are limited to using the combination medicaldevice in the dosage and strength produced, without flexibility to alterthe product as needed for their respective patients.

Therefore, the present disclosure describes a package for a medicaldevice aimed at simplifying the design and application of combinationmedical device coatings to provide the following benefits: the abilityto choose any bioactive or non-bioactive agent necessary for theindividual patient without having to change existing products ormanufacturing process; sensitive agents can be delivered withoutcompromising standard shelf or transport conditions; the ability tolater combine a specific medical device with agents that were unable totolerate the required sterilization process for that specific device,under sterile conditions; the medical professional has greater controlover product selection; and longer shelf-life of products due to morestable format.

SUMMARY

A package for a medical device in accordance with the present disclosureincludes a cavity configured and dimensioned to receive a medicaldevice, a first closure for sealing the medical device within thecavity, the first closure including a sealed portal therein foraccessing the medical device and a second closure positioned adjacentthe first closure and surrounding the sealed portal.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are described herein with reference to the drawingswherein:

FIG. 1 is a perspective view of a package for a medical device in aclosed position;

FIG. 2 is a perspective view of a package for a medical device in anopen position;

FIG. 3 is a perspective view of a package for a medical device having adelivery device attached to the sealed portal for passing an agentbetween the outside of the package and the inside of the cavity; and

FIG. 4 is a perspective view of a package for a medical device includinga third closure.

DETAILED DESCRIPTION

The present disclosure describes packages for one or more medicaldevice(s) which include a cavity which is configured and dimensioned toreceive a medical device. The packages also include a first closure anda second closure. The first closure includes a sealed portal and isdesigned to seal the medical device within the cavity. The secondclosure is positioned adjacent the first closure with the ability tosurround the sealed portal. The sealed portal is defined within thefirst closure and allows for the passage of an agent between the outsideof the package and the inside of the cavity.

It is envisioned that the first closure which includes a sealed portaldefined therein and the second closure which is positioned adjacent thefirst closure may be positioned together along any side, edge or cornerof the package. The first closure being dimensioned appropriately toseal the cavity which receives the medical device while including roomto have a sealed portal defined therein. The second closure beingdimensioned appropriately to surround the sealed portal defined withinthe first closure. In embodiments, the first and second closure may bemade of the same size and dimension. In other embodiments, the first andsecond closures may be made of different size and dimension.

The sealed portal which is defined within the first closure is designedto permit the passage of at least one agent between the outside of thepackage and the medical device positioned within the cavity. It isenvisioned that the portal may be made of any size, shape or dimensionand may also be positioned along any side, edge or corner of the firstclosure.

In embodiments, the portal may be an injectable-hub which is designed toremain sealed by self-sealing action to ensure no fluid medium canescape and also so no pathogens can breach the package. Theinjectable-hub would require a delivery device to include some sort ofsharpened edge to penetrate the hub such as a needle or beveled edge ofintravenous tubing systems. The portal can be composed of a traditionalrubber or thermoplastic material known to be used in sealing sterilevials, intravenous bags, catheters, drug ampules or blood bags.Alternatively, the portal may be composed of hydrophobic, hydrophilic ora combination of hydrophobic and hydrophilic materials.

In embodiments, the portal may be a hub designed in such a way that onlya particular syringe can mate with the portal thereby creating a lockand key type of hub to promote only specific use of the portal. Thistype of portal provides more safety to the user of portal because theportal does not necessarily require the use of a needle. In addition,the lock and key type of hub may be used by patients and medical stafffor only certain medications and dosages of those medications, therebyreducing the likelihood of administering the wrong agent or the wrongdosage of the intended agent.

The sealed portal may be accessed to allow the passage of at least oneagent between the outside of the package and the inside of the cavity.The agent may be passed through the sealed portal as a solid, liquid,semi-solid, gas, or any combination thereof. The at least one agent maybe selected from any bioactive and/or non-bioactive agent suitable forcombination with the medical device. Suitable agents include, but arenot limited to, drugs, such as antiseptics, anesthetics, musclerelaxants, antihistamines, decongestants, antimicrobial agents,anti-viral agents, anti-fungal agents, antimalarials, amebicides,antituberculosal agents, antiretroviral agents, leprostatics,antiprotazoals, antihelmitics, antibacterial agents, steroids,hematopoietic agents, antiplatelet agents, anticoagulants, coagulants,thrombolytic agents, hemorrheologic agents, hemostatics, plasmaexpanders, hormones, sex hormones, uterine-active agents,bisphosphonates, antidiabetic agents, glucose-elevating agents, growthhormones, thyroid hormones, inotropic agents, antiarrhythmic agents,calcium channel blockers, vasodilators, sympatholytics,antihyperlipidemic agents, vasopressors, angiotensin antagonists,sclerosing agents, anti-impotence agents, urinary alkanizers, urinaryacidifiers, anticholinergics, diuretics, bronchodilators, surfactants,antidepressants, antipsychotics, antianxiety agents, sedatives,hypnotics, barbiturates, antiemetic agents, analgesics, stimulants,anticonvulsants, antiparkinson agents, proton pump inhibitors,H₂-antagonists, antispasmodics, laxatives, antidiarrheals,antiflatulents, digestive enzymes, gallstone solubilizing agents,antihypertensive agents, cholesterol-lowering agents, radiopaque agents,immune globulins, monoclonal antibodies, antibodies, antitoxins,antivenins, immunologic agents, anti-inflammatory agents, antineoplasticagents, alkylating agents, antimetabolites, antimitotic agents,radiopharmaceuticals, vitamins, herbs, trace elements, amino acids,enzymes, chelating agents, immunomodulatory agents and immunosuppressiveagents; coating materials such as lubricants, and non-bioabsorbablesubstances such as silicone, beeswax, or polytetrafluoroethylene, aswell as absorbable substances such as collagen, chitosan, chitin,carboxymethylcellulose, and homopolymers and/or copolymers ofpolyalkylene glycols, and higher fatty acids or salts or esters thereof,glycolic acid, a glycolide, lactic acid, a lactide, p-dioxanone,valerolactone and other lactones derived from linear aliphatichydroxycarboxylic acids, α-hydroxybutyric acid, ethylene carbonate,ethylene oxide, propylene oxide, propylene carbonate, malic acid esterlactones, succinic acid, adipic acid and other linear aliphaticdicarboxylic acids, and linear aliphatic diols such as butanediol andhexanediol; wound healing agents; adhesives; sealants; blood products;blood components; preservatives; colorants; dyes; ultraviolet absorbers;ultraviolet stabilizers; photochromic agents; anti-adhesives; proteins;polysaccharides; peptides; genetic material; viral vectors; nucleicacids; nucleotides; plasmids; lymphokines; radioactive agents; metals;alloys; salts; growth factors; growth factor antagonists; cells;hydrophobic agents; hydrophilic agents; immunological agents;anti-colonization agents; diagnostic agents; imaging agents;cross-linking agents; and diluents, such as water, saline, dextrose. Ofcourse any combination of these agents may also be passed to the medicaldevice contained in the package.

The packages as described herein may be made from a variety of materialsor combination of materials. Some suitable materials for forming thepackages described herein include, but are not limited to, polymericmaterials, thermoplastic materials, ceramic materials, metallicmaterials and combinations thereof. The materials may be transparent,semi-transparent or opaque. Although any natural or synthetic polymericmaterial may be used to form the packages, some non-limiting examplesinclude polymers, copolymers, homopolymers, block copolymers, and randomcopolymers including materials such as polyethylene, polypropylene,polycarbonates, polyesters, polycaprolactone, polyethylene terphthalate,and polysiloxanes.

The size and shape of the package is selected to provide a cavityappropriate to receive a particular medical device or devices. Forexample, packages for a vascular graft or tissue-based implant aregenerally cylindrical, while packages for a mesh, suture and the likeare generally rectangular. Since medical devices vary in size and shape,it is envisioned that the size and shape of the packages describedherein may vary accordingly to accommodate such devices. For example,the packages described herein may be generally rectangular, circular,octagonal, cylindrical, pentagonal, hexagonal, and the like.

In embodiments, the medical device may be withdrawn from the originalcontainer in which it was stored or shipped and placed within the cavityof the package. In embodiments, the medical device may remain positionedwithin the original container in which it was stored or shipped and theentire container including the medical device may be received within thecavity of the packages described herein.

The packages are configured and dimensioned to receive any medicaldevice. Any medical device may be received within the package, includingimplantable, transplantable or prosthetic materials which are designedto remain in the body for at least some time.

Appropriate medical devices can be made from natural material, syntheticmaterial or a combination of natural and synthetic material. Examples ofnatural materials include, for example, intact tissues as well asdecellularized tissue. These tissues are often derived from a particularanimal species such as human, bovine, porcine, shark and the like, andmay be obtained from, for example, natural heart valves; portions ofnatural heart valves such as roots, walls and leaflets; pericardialtissues such as pericardial patches; connective tissues; bypass grafts;tendons; ligaments; skin patches; blood vessels; cartilage; dura matter;skin; bone; umbilical tissues; GI tract tissues; and the like. Thesenatural tissues generally include collagen-containing material.

The devices may also be formed from tissue equivalents such as atissue-engineered material involving a cell-repopulated matrix, whichcan be formed from polymers, biopolymers or from a decellularizednatural tissue. Biopolymers can be naturally occurring or produced invitro by, for example, fermentation and the like. Purified biopolymerscan be appropriately formed into a substrate by techniques such asweaving, knitting, casting, molding, extrusion, cellular alignment andmagnetic alignment.

Synthetic materials that can be used to form the medical devicesdescribed herein include a variety of biocompatible materials such asmetals, polymers, ceramics and combinations thereof. Appropriatepolymers include, for example, hydrogels, bioabsorbable materials andnon-bioabsorbable materials.

Suitable non-limiting examples of medical devices which may be receivedwithin the packages described herein, include: sutures, staples, clips,pledgets, buttresses, suture anchors, cables, wires, pacemakers, stents,catheters, inflatable devices, adhesives, sealants, meshes, sternumclosures, pins, screws, tacks, rods, plates, adhesion barriers,bioelectronic devices, dental implants, surgical tools and combinationsthereof.

Referring now to FIGS. 1-4, package 10 as described herein includescavity 15 which is configured and dimensioned to receive medical device20, first closure 25 for sealing medical device 20 within cavity 15,first closure 25 having sealed portal 40 defined therein for accessingmedical device 20 and second closure 30 which is positioned adjacentfirst closure 25 and surrounds sealed portal 40.

In FIG. 1, package 10 is shown in the closed or sealed position. In theclosed position, first closure 25 prevents cavity 15 and any contentscontained in cavity 15 including medical device 20 from being accessedfrom outside package 10 except for passage through sealed portal 40.Second closure 30 is adjacent first closure 25 and surrounds sealedportal 40. In the closed position, second closure 30 prevents access tosealed portal 40 thereby preventing the passage of a bioactive agentthrough sealed portal 40 and between the outside of package 10 andcavity 15.

Turning to FIG. 2, package 10 is shown in a first open position whereinfirst closure 25 is positioned away from cavity 15 thereby allowingdirect access into cavity 15 of package 10. In the first open position,a container 22 for storing a medical device 20 may be positioned withinor withdrawn from cavity 15. In embodiments, container 22 may be asuture retainer and medical device 20 may be a suture. As shown, secondclosure 30 may remain surrounding sealed portal 40 and adjacent firstclosure 25 while package 10 and first closure 25 are positioned in anopen position. In embodiments, second closure 30 may also be positionedaway from sealed portal 40 to allow access to sealed portal 40 whilepackage 10 and first closure 25 are in the open position (not shown).

First closure 25 may be attached to cavity 15 using any mechanical meanssuitable for allowing first closure 25 to move from the open position tothe closed position as described herein. In embodiments, first closure25 and cavity 15 may be formed from separate materials as a structurewhich is not monolithic. The separate materials may be attached to eachother using a connecting member. Suitable connecting members includeknown devices which attach at least a portion of first closure 25 to atleast a portion of cavity 15 and allow first closure 25 to pivot aboutleading edge 17 of cavity 15 to seal medical device 20 with cavity 15. Aparticularly useful connecting member includes a hinge or hinge-likedevice.

In embodiments, first closure 25 and cavity 15 are formed as amonolithic structure wherein at least a portion of first closure 25 isdirectly attached to a portion of cavity 15. The monolithic structureincludes a naturally pivotable portion which is positioned along leadingedge 17 of cavity 15 which connects first closure 25 to cavity 15 andallows first closure 25 to pivot and seal medical device 20 withincavity 15.

Also in FIG. 2, package 10 is shown receiving medical device 20including the container 22 which medical device 20 is stored, shipped ormanufactured in. In embodiments, container 22 may include a port whichis capable of connecting to sealed portal 40 when cavity 15 is closed byfirst closure 20 (See FIG. 3)

In addition, FIG. 2 shows package 10 further including at least oneguide member 50. Guide member 50 is positioned within cavity 15 toassist with the loading of medical device 20 into cavity 15 of package10. In addition guide member 50 may be utilized to position medicaldevice 20 within cavity 15 at a certain angle, height, depth, etc. Guidemember 50 may also be used to prevent medical device 20 from movingaround within cavity 15. As shown, guide member 50 is a slot whichextends a predetermined length inside cavity 15 and which is dimensionedto receive the edge of medical device 20 thereby locking medical deviceinto position within cavity 15. Suitable guide members include thosedevices which assist with properly positioning the medical device withincavity 15 and include for example, tabs, tracks, hooks, footings and thelike.

Turning now to FIG. 3, package 10 is shown with medical device 20 sealedwithin cavity 15 by first closure 25. Second closure 30 is pivoted awayfrom sealed portal 40 thereby allowing delivery device 70 access tosealed portal 40. Medical device 20 is stored in container 22 whichincludes port 24. Port 24 is positioned on container 22 to engage sealedportal 40 when cavity 15 is sealed by first closure 25. Delivery device70 is shown accessing sealed portal 40 and in position to permit thepassage of an agent between the outside of package 10 and the inside ofcavity 15. In embodiments, delivery device 70 may include any devicecapable of engaging or accessing sealed portal 40 and delivering theagent through sealed portal 40. Suitable non-limiting examples include,needles, syringes, infusion pumps, and IV delivery systems.

In embodiments, package 10 may further include third closure 90 asdepicted in FIG. 4. Third closure 90 is positioned on the distal end ofpackage 10. As defined herein, the proximal end of package 10 is meantto include the end nearest second closure while the distal end is meantto include the end of package 10 which is farthest from second closure.Third closure 90 is designed to allow medical device 20 from beingwithdrawn from or received into cavity 15 of package 10.

It is well understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplifications ofparticularly useful embodiments. Those skilled in the art will envisionother modifications within the scope and spirit of the claims appendedhereto.

1. A package for a medical device, the package comprising: a firstcavity configured and dimensioned to receive a medical device; a firstclosure for sealing the medical device within the first cavity, thefirst closure having a sealed portal therein for accessing the medicaldevice, and a second closure positioned adjacent the first closure, thesecond closure surrounding the portal.
 2. The package of claim 1 whereinthe medical device is selected from the group consisting of sutures,staples, clips, pledgets, buttresses, suture anchors, cables, wires,pacemakers, stents, catheters, inflatable devices, adhesives, sealants,meshes, sternum closures, pins, screws, tacks, rods, plates, adhesionbarriers, bioelectronic devices, dental implants, surgical tools andcombinations thereof.
 3. The package of claim 1 wherein the medicaldevice is a suture.
 4. The package of claim 1 wherein the at least oneagent is selected from the group consisting of drugs, coating materials,diluents, wound healing agents, adhesives, sealants, blood products,blood components, preservatives, colorants, dyes, ultraviolet absorbers,ultraviolet stabilizers, photochromic agents, anti-adhesive agents,proteins, polysaccharides, peptides, genetic material, viral vectors,nucleic acids, nucleotides, plasmids, lymphokines, radioactive agents,cross-linking agents, metals, alloys, salts, growth factors, growthfactor antagonists, cells, immunological agents, anti-colonizationagents, diagnostic agents, imaging agents, and combinations thereof. 5.The package of claim 1 wherein the at least one agent is a drug.
 6. Thepackage of claim 5 wherein the drug is selected from the groupconsisting of antiseptics, anesthetics, muscle relaxants,antihistamines, decongestants, antimicrobial agents, anti-viral agents,anti-fungal agents, antimalarials, amebicides, antituberculosal agents,antiretroviral agents, leprostatics, antiprotazoals, antihelmitics,antibacterial agents, steroids, hematopoietic agents, antiplateletagents, anticoagulants, coagulants, thrombolytic agents, hemorrheologicagents, hemostatics, plasma expanders, hormones, sex hormones,uterine-active agents, bisphosphonates, antidiabetic agents,glucose-elevating agents, growth hormones, thyroid hormones, inotropicagents, antiarrhythmic agents, calcium channel blockers, vasodilators,sympatholytics, antihyperlipidemic agents, vasopressors, angiotensinantagonists, sclerosing agents, anti-impotence agents, urinaryalkanizers, urinary acidifiers, anticholinergics, diuretics,bronchodilators, surfactants, antidepressants, antipsychotics,antianxiety agents, sedatives, hypnotics, barbiturates, antiemeticagents, analgesics, stimulants, anticonvulsants, antiparkinson agents,proton pump inhibitors, H₂-antagonists, antispasmodics, laxatives,antidiarrheals, antiflatulents, digestive enzymes, gallstonesolubilizing agents, antihypertensive agents, cholesterol-loweringagents, radiopaque agents, immune globulins, monoclonal antibodies,antibodies, antitoxins, antivenins, immunologic agents,anti-inflammatory agents, antineoplastic agents, alkylating agents,antimetabolites, antimitotic agents, radiopharmaceuticals, vitamins,herbs, trace elements, amino acids, enzymes, chelating agents,immunomodulatory agents, immunosuppressive agents and combinationsthereof.
 7. The package of claim 1 wherein the agent is a diluentselected from the group consisting of water, saline, dextrose andcombinations thereof.
 8. The package of claim 1 wherein the package is amonolithic structure.
 9. The package of claim 1 further comprising athird closure.
 10. The package of claim 9 wherein the third closure ispositioned at the distal end of the package.
 11. A method of packaging amedical device comprising: providing a medical device; and placing themedical device in the package of claim
 1. 12. A packaged medical devicecomprising: a suture; a first cavity configured and dimensioned toreceive the suture; a first closure for sealing the suture within thefirst cavity, the first closure having a sealed portal therein foraccessing the suture, and a second closure positioned adjacent the firstclosure, the second closure surrounding the portal.